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Juvéderm Volite

Juvéderm Volite

Juvederm

Aesthetics
  • CE Marked Class III sterile injectable hyaluronic acid gel for dermal use in applicable markets.
  • Manufactured under ISO 13485 Compliant quality management systems for medical devices.
  • Conforms to relevant EU/UK medical device regulations for hyaluronic acid dermal fillers and skin Quality implants.
Skin booster / hydrating hyaluronic acid dermal filler

Description

Juvéderm Volite with Lidocaine (2 x 1.0 ml) is an injectable, cross-linked hyaluronic acid dermal filler designed specifically to improve skin quality. Using VYCROSS technology to combine low- and high-molecular-weight HA, it provides long-lasting hydration, elasticity and smoothness with minimal volumising, making it ideal as a skin booster rather than a traditional volumising filler. Volite is indicated for superficial intradermal injection in the face, neck, décolletage and hands to enhance skin hydration, texture and elasticity. Each syringe contains 12 mg/ml hyaluronic acid and 3 mg/ml lidocaine hydrochloride in a phosphate buffer, giving comfortable treatment and results that typically last 6–9 months after a single session.

Bnefits

  • Improves overall skin quality, including hydration, elasticity and smoothness.
  • Acts as a skin booster with minimal bulk, giving a fresher, more youthful appearance without over-filling.
  • Suitable for use on the face, neck, décolletage and hands.
  • VYCROSS technology (combination of low- and high-molecular-weight HA) enhances cross-linking efficiency and durability.
  • Delivers results that commonly last 6–9 months after one treatment session, depending on baseline skin condition and lifestyle.
  • Contains 0.3% lidocaine to increase patient comfort and reduce injection pain.
  • Biocompatible, biodegradable hyaluronic acid of non-animal origin.
  • Can be used on skin with early signs of ageing to improve fine lines, texture and glow.

Indications

  • Treatment, by filling, of superficial cutaneous depressions such as fine lines.
  • Improvement of skin quality attributes such as hydration, elasticity and smoothness.
  • Skin quality enhancement of the face.
  • Skin quality enhancement of the neck.
  • Skin quality enhancement of the décolletage.
  • Skin quality enhancement of the hands.
  • Use as a skin booster in patients with early signs of skin ageing who desire improved texture and radiance.

Composition

  • Hyaluronic acid gel 12.0 mg/ml (cross-linked, non-animal origin).
  • Lidocaine hydrochloride 3.0 mg/ml (0.3%) as a local anaesthetic.
  • Phosphate buffer pH 7.2 q.s. to 1 ml.

Formulation

  • Sterile, pyrogen-free, physiological solution of cross-linked hyaluronic acid (not of animal origin).
  • Clear, colourless, viscoelastic gel implant presented in graduated, pre-filled disposable syringes.
  • Hyaluronic acid 12 mg/ml with 3 mg/ml lidocaine in a phosphate-buffered solution (pH ~7.2).
  • Formulated using VYCROSS technology to optimise smoothness, longevity and integration into superficial dermis.
  • Intended for superficial intradermal injection by specially trained medical practitioners.

Packaging

  • Box containing two 1.0 ml pre-filled glass syringes of Juvéderm Volite with Lidocaine.
  • Four single-use sterile 32G 1/2" needles supplied for use with the syringes.
  • Instruction leaflet / Directions for Use.
  • Traceability labels (for patient and practitioner records).
  • Syringes and needles packaged in a sterile blister within an outer carton.

Usage

  • For professional use only; must be administered by a suitably trained and licensed healthcare professional experienced in intradermal injection techniques.
  • Assess the patient’s medical history, indications and expectations; obtain informed consent before treatment.
  • Cleanse and disinfect the treatment area thoroughly using appropriate antiseptic measures.
  • Attach a supplied 32G 1/2" sterile needle (or other suitable sterile needle/cannula per local practice) to the syringe and expel air before injection.
  • Inject the gel as multiple small aliquots into the superficial to mid dermis using micro-droplet or serial puncture technique, avoiding intravascular injection.
  • Typical treatment pattern involves evenly spaced injections over the selected area (face, neck, décolletage or hands) to create a uniform improvement in skin quality.
  • Do not overcorrect; small volumes should be deposited at each point, and the skin should not appear excessively raised after injection.
  • Gently massage the treated area after injection to ensure even distribution of the product if clinically appropriate.
  • Advise patients to avoid makeup, intense heat/cold exposure, strenuous exercise and alcohol for roughly 12–24 hours post-treatment, and to follow practitioner-specific aftercare instructions.
  • Each syringe is single-use only; discard any unused product, needles and syringes as clinical sharps waste.

Contraindications

  • Known hypersensitivity to hyaluronic acid or any of the excipients.
  • Known hypersensitivity to lidocaine or other amide-type local anaesthetics.
  • Known allergy to gram-positive bacterial proteins (HA is produced by Streptococcus species).
  • Presence of active skin disease, inflammation, infection or lesions (e.g. acne, dermatitis, herpes) at or near the intended injection sites.
  • History of severe allergic reactions or anaphylaxis.
  • Bleeding disorders or use of anticoagulant/antiplatelet therapy that increases bleeding risk, unless carefully evaluated by the treating physician.
  • Previous permanent filler or implant in the planned treatment area (relative contraindication; requires individual risk–benefit assessment).
  • Pregnancy or breastfeeding due to insufficient clinical safety data.
  • Patients under 18 years of age.
  • Autoimmune diseases or immunosuppression where dermal filler use may pose additional risks, unless the physician determines treatment is appropriate after assessment.

Adverse Effects

  • Common injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching, bruising or warmth, usually resolving within a few days.
  • Transient papules, small lumps, nodules or irregularities at injection sites that generally improve as the product integrates and/or with gentle massage.
  • Temporary firmness or induration in the treated area.
  • Haematoma or prolonged bruising, particularly in more vascular regions.
  • Localised discoloration or hyperpigmentation in susceptible individuals.
  • Rare inflammatory reactions including granuloma or persistent nodule formation.
  • Hypersensitivity or allergic reactions (immediate or delayed) to hyaluronic acid, lidocaine or other components.
  • Infection or abscess formation at the injection site if aseptic technique is not strictly followed.
  • Very rare but serious vascular complications if product is inadvertently injected into a blood vessel, potentially leading to tissue ischemia or necrosis; this risk is lower for superficial intradermal treatments but must still be considered.

Storage Conditions

  • Store in the original unopened packaging in a clean, dry place.
  • Maintain storage temperature between 2°C and 25°C, as stated on the outer carton.
  • Do not freeze.
  • Protect from direct sunlight and excessive heat.
  • Do not use if the blister, syringe or needles are damaged, opened or contaminated.
  • Do not use after the expiry date printed on the packaging and syringe labels.

Duration

Typical clinical effects of Juv\u00e9derm Volite with Lidocaine last approximately 6\u20139 months after a single treatment session, depending on the patient\u2019s baseline skin condition, area treated, injection technique and lifestyle factors.

Onset

Initial improvement in skin hydration and smoothness is usually visible within days of treatment, with optimal results generally reached over 2\u20134 weeks as the gel integrates and skin quality parameters (texture, elasticity, radiance) continue to improve.

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